Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 18-50 years of both sexes. 2.History of segmental low back pain of lumbar (L5) or sacral (S1) origin with radiation to unilateral lower limb below knee of less than 1-month duration. 3.Patients who are not the candidates for surgery. 4.Average pain score of >=4 on an 11-point NRS. 5.Tenderness over the concordant peripheral nerves (Gore sign +) 6.Magnetic resonance imaging (MRI) evidence of nerve root pain concordant with the side and level of clinical features.
Exclusion criteria
Exclusion criteria: 1.Coagulopathy and/or patients on anticoagulants. 2.Infection at the site of injection. 3.Hypersensitivity to local anesthetic agent. 4.Evidence of significant progressive sensory or motor deficit, cauda-equina syndrome, H/O trauma, infection and cancer (Red flag signs). 5.Evidence of severe psychiatric illness. 6.History of previous backs surgery/epidural steroid injection. 7.History of any major comorbid medical conditions, those interfere with recording of study outcomes (any auto-immune diseases), multiple sclerosis, and pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10 immediately after the procedure, at 2 weeks and at 2 and 3 months after the procedureTimepoint: 1.Pain relief as assessed by Numerical Rating Scale (NRS) on a scale of 1-10 immediately after the procedure, at 2 weeks and at 2 and 3 months after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in biomarkers of pain before and after distal nerve block (high sensitive C reactive protein, tumor necrosis factor-alpha, interleukin 6, interleukin-4) 2.Physical functioning as assessed by Roland Morris Questionnaire (Annexure â??II) 3.Global Perceived Effects (Annexure-III) 4.To assess spontaneous reporting of adverse effects and the incidence of complications due to the procedure. Timepoint: Changes in biomarkers of pain before and after distal nerve block | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Rishikesh